The following links are useful to the pharmacovigilance community.

International Society of Pharmacovigilance • The International Society of Pharmacovigilance (ISoP) is an international non-profit scientific organization, which aims to foster Pharmacovigilance both scientifically and educationally. ISoP publishes the journal Drug Safety.

Drug Information Association • The Drug Information Association is the largest trade organization for the biopharmaceutical industry. They host the Clinical Safety and Pharmacovigilance online community.

International Society of Pharmacoepidemiology • The International Society for Pharmacoepidemiology (ISPE) is an international organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, and therapeutic risk management.

ICH • The International Conference on Harmonization.

CIOMS • The Council for International Organizations of Medical Sciences.

Oracle Clinical Users Group • The Oracle Clinical User Group is the home of the Oracle AERS Users Group.

US FDA • The US Food and Drug Administration includes the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health which collectively oversee all aspects of biopharmaceutical and medical device products.

FDA MedWatch • The MedWatch Program captures all adverse event and product complaint reports for drugs and devices.

FDA Electronic Submissions • The FDA Electronic Submission Gateway (ESG) is the central gateway for all electronic submissions to the US FDA, include E2B Submissions. The specific guidance for E2B submissions for CDER can be found at the AERS Electronic Submissions page.

Health Canada • Health Canada is the Canadian public health department. Specific regulation for medical products is managed by the department of Drugs and Health Products.

EMEA • The European Medicines Agency (EMEA) is a decentralized body of the European Union and is responsible for the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The European Union guidance for pharmacovigilance are delineated in Volume 9A.

MHRA • The Medicines and Healthcare products Regulatory Agency regulates medical products in the United Kingdom.

AFSSaPs • The Agence Française de Sécurité Sanitaire des Produits de santé regulates medical products in France.

EudraVigilance • EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorization of medicinal products in the European Economic Area (EEA).

MHLW • The Ministry of Health, Labor and Welfare is the umbrella regulatory agency in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) oversees new product and surveillance.

The following vendors provide software and services supporting pharmacovigilance activities:

Oracle® • Products include the , Argus Safety™ Suite, Oracle AERS and Oracle TMS, Oracle Business Analytics, and Siebel Call Center.

Aris Global™ • Products include ARISg™ and a comprehensive suite of integrated add-on pharmacovigilance products, as well as Register™ a leading regulatory affairs tracking system.

PhaseForward • Products include the Empirica™ Suite, which delivers Adverse Event Reporting, Data Mining, Signal Detection and Signal Management capabilities.

DrugLogic® • DrugLogic offers the Qscan® product and services for the analysis and generation of safety signals from your adverse event data.

MSSO • The MSSO manages the distribution and content of MedDRA.

The Uppsala Monitoring Centre (UMC) • The UMC is responsible for the management of the WHO Programme for International Drug Monitoring and offer several products to industry. They maintain and license WHO Drug Dictionary, an industry standard drug dictionary. They also offer comprehensive pharmacovigilance analysis tools, Vigibase based on the international WHO repository of adverse events.